RECENT NEWS

Point-of-care diagnostics company Nanopath has been awarded $4 million in funding from US Federal agencies. The company was awarded a $3 million grant from the National Institutes of Health (NIH) and a $1 million grant from the National Science Foundation (NSF) to support continued research and development of the company's point-of-care diagnostic platform for pelvic and gynaecologic infections.

Roche and Hitachi High-Tech have announced the extension of the partnership between the two companies, committing to at least 10 years of additional collaboration. Bringing together Roche and Hitachi’s expertise and track record in diagnostics innovation, engineering and manufacturing, the renewed contract further strengthens the long-lasting partnership.

NHS patients in England are set to benefit from faster access to new medical technologies under new plans. Proposals set out in a joint NHS England and NICE consultation outline a new route for medtech developers to access NHS funding to fast-track clinically and cost-effective products for use by the healthcare system.

The Medicines and Healthcare products Regulatory Agency (MHRA) has published a statement of policy intent for international recognition of medical devices.

The Australian Centre for the Prevention of Cervical Cancer (ACPCC), a not-for-profit organisation with 60 years of expertise in cervical cancer prevention, has partnered with Cirdan to implement a state-of-the-art laboratory information management system (LIMS) to optimise and future-proof its laboratory workflows.

BIVDA has welcomed a statement of policy intent published by MHRA for recognition by the UK of approvals of medical devices from international regulators.

The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a four-week consultation which will support improved safety for certain high-risk IVD devices.

Karius has announced that its Karius Test has been granted designation as a Breakthrough Device from the Center for Devices and Radiological Health (CDRH) of the US FDA, for use in the diagnosis and management of immunocompromised patients with suspected lung infections including lower respiratory infection and pneumonia.

Ibex Medical Analytics and Kameda Medical Center (Kameda), both feature in a newly published clinical study evaluating Ibex's Galen platform, which demonstrated excellent outcomes in detecting cancer and other pathologies in prostate and breast biopsies.

Sysmex has been recognised in the ‘Great Place to Work’ scheme, receiving the 41st position in the ‘Best Workplaces 2024 – Large Category’ list, after being certified last November. In 2023 Sysmex UK was also recognised as a Great Place to Work for wellbeing.

The National Institute for Health and Care Research (NIHR) has awarded £5 million for an NIHR HealthTech Research Centre Network, hosted by Sheffield Teaching Hospitals NHS Foundation Trust, from 1 September 2024.

Backed by a new award of £1.8 million, the Medicines and Healthcare products Regulatory Agency (MHRA) is to establish a dedicated team to provide regulatory scientific support for innovators creating novel antimicrobials and diagnostics as part of a programme led by the Department of Health and Social Care (DHSC) to support the international community in tackling the growing threat of antimicrobial resistance (AMR).

PathAI has announced the launch of Pathology Universal Transformer (PLUTO), a pathology-centric foundation model, to further differentiate the company’s portfolio of products geared towards biopharma and pathology laboratory customers.

Thermo Fisher Scientific has introduced the Applied Biosystems Axiom BloodGenomiX array and software, a first-of-its-kind solution for more precise blood genotyping in clinical research.

A package of up to £85 million to support the international community in tackling the growing threat of antimicrobial resistance has been announced by the UK Government.

Indica Labs has announced that it received FDA clearance for HALO AP Dx, an enterprise digital pathology platform, for primary diagnosis. This 510(k) clearance allows HALO AP Dx to be utilised in conjunction with the Hamamatsu NanoZoomer S360MD Slide scanner for in-vitro diagnostic use and sets the stage for use with additional FDA-cleared slide scanners in the future.

Danaher has launched a collaboration with Johns Hopkins University aiming to develop new methods for diagnosing mild traumatic brain injury (TBI). As part of the Danaher Beacons program, researchers at Johns Hopkins University will leverage technology from Danaher subsidiary Beckman Coulter Diagnostics to potentially establish correlations between a new biomarker panel and clinical outcomes.

Harnessing the power of CRISPR gene-editing technology in a new way, University of Florida researchers have created a one-tube testing method targeting DNA from body fluids that has the potential to dramatically increase access to the diagnosis of viral diseases such as cervical cancer.

A newly discovered Zika virus-specific synthetic molecule is capable of differentiating Zika-immune patient samples from samples of patients previously infected with the related dengue virus. The technology may lead to the development of better diagnostics and vaccine candidates.

Applied Cells has announced the launch of its MARS Ingenuity Reagent kits for fast and easy cell isolation. This innovative product line features both RUO and GMP-grade reagents, and has been specifically optimised for use on Applied Cells’ proprietary MARS Bar platform.